Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Efficacy and Safety of IMU-838 for Induction and Maintenance Therapy in Moderate-to-severe Ulcerative Colitis
Sponsor: Immunic AG
Terminated
Considering the efficacy results of the induction phase (allowed use of corticosteroids as concomitant medication) in the study population and since IMU-838 did not show superiority over placebo, the OLE was prematurely closed by the sponsor.
Other terminated trials from Immunic AG
More terminations from Immunic AG
Other Ulcerative Colitis trials with similar outcome
A PHASE2 clinical study on Ulcerative Colitis, this trial is terminated or withdrawn. The trial is conducted by Immunic AG and has accumulated 22 data snapshots since 2018. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Status Flow
Change History
22 versions recorded-
Sep 2025 — Present [monthly]
Terminated PHASE2
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Sep 2024 — Sep 2025 [monthly]
Terminated PHASE2
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Jul 2024 — Sep 2024 [monthly]
Terminated PHASE2
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Apr 2024 — Jul 2024 [monthly]
Terminated PHASE2
Status: Active Not Recruiting → Terminated
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Mar 2023 — Apr 2024 [monthly]
Active Not Recruiting PHASE2
▶ Show 17 earlier versions
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Nov 2022 — Mar 2023 [monthly]
Active Not Recruiting PHASE2
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May 2022 — Nov 2022 [monthly]
Active Not Recruiting PHASE2
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Nov 2021 — May 2022 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
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Sep 2021 — Nov 2021 [monthly]
Recruiting PHASE2
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Jun 2021 — Sep 2021 [monthly]
Recruiting PHASE2
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May 2021 — Jun 2021 [monthly]
Recruiting PHASE2
-
Apr 2021 — May 2021 [monthly]
Recruiting PHASE2
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Mar 2021 — Apr 2021 [monthly]
Recruiting PHASE2
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Feb 2021 — Mar 2021 [monthly]
Recruiting PHASE2
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Jan 2021 — Feb 2021 [monthly]
Recruiting PHASE2
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Aug 2020 — Jan 2021 [monthly]
Recruiting PHASE2
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Mar 2020 — Aug 2020 [monthly]
Recruiting PHASE2
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Feb 2020 — Mar 2020 [monthly]
Recruiting PHASE2
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Apr 2019 — Feb 2020 [monthly]
Recruiting PHASE2
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Jun 2018 — Apr 2019 [monthly]
Recruiting PHASE2
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Apr 2018 — Jun 2018 [monthly]
Recruiting PHASE2
Status: Not Yet Recruiting → Recruiting
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Dec 2017 — Apr 2018 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Immunic AG
For direct contact, visit the study record on ClinicalTrials.gov .